Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Siemens Healthcare Diagnostics Inc. ADVIA Centaur CA 19-9 [Lots: 55970535, 55971535, 55972535, 55973535] [HKMD number: 210417].
According to the TGA, there is a positive bias in some samples around a concentration of 37 U/mL with lots 55970535, 55971535, 55972535, 55973535 when compared to the previous lot. A sample bias was observed in the Asia Pacific sample population. The observed bias is not proportional across the assay measuring interval and is less pronounced for sample results above a concentration of 110 U/mL.
For further information, please visit: https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2024-RN-00652-1
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 5 Aug 2024